From the FDA Drug Label
CONTRAINDICATIONS Neonates and patients with a history of hypersensitivity to dimenhydrinate or its components (diphenhydramine or 8-chlorotheophylline) should not be treated with dimenhydrinate. Note: This product contains Benzyl Alcohol. Benzyl Alcohol has been associated with a fatal “Gasping Syndrome” in premature infants and infants of low birth weight.
- Dimenhydrinate is not safe for use in infants under 2 years of age, particularly neonates, due to the risk of fatal "Gasping Syndrome" associated with Benzyl Alcohol in premature infants and infants of low birth weight 1.
From the Research
Dimenhydrinate is not recommended for use in infants under 2 years of age without specific medical guidance. The most recent and highest quality study available is from 2, which highlights the risk of dimenhydrinate intoxication in infants, particularly when suppositories are given repeatedly. This study reported a case of a 13-month-old girl who suffered from generalized tonic-clonic seizures after receiving dimenhydrinate suppositories, emphasizing the potential for severe adverse effects in this age group.
Key Considerations
- The FDA has not approved dimenhydrinate for children younger than 2 years old due to safety concerns and limited research on its effects in this age group 3.
- Young infants are particularly vulnerable to potential side effects of antihistamines like dimenhydrinate, including sedation, paradoxical excitation, breathing problems, and seizures.
- Their immature liver and kidney function can affect how the medication is processed in their bodies, potentially leading to unpredictable responses or toxicity even at low doses.
Alternative Approaches
- For motion sickness or vomiting in infants under 2, parents should consult a pediatrician who may recommend safer alternatives such as:
- Positioning techniques
- Smaller and more frequent feedings
- Other age-appropriate interventions
- If travel is necessary, non-medication approaches like scheduling trips during nap times, ensuring good ventilation, and making frequent stops may help manage motion sickness symptoms in infants.
Important Note
While some studies suggest that dimenhydrinate may be effective in reducing nausea and vomiting in certain populations, such as pregnant women 4, the risks associated with its use in infants under 2 years of age outweigh any potential benefits, and alternative approaches should be prioritized.